cannabidiol oral solution (RAD011) / Radius, Benuvia Therap - LARVOL DELTA

SCOUT-015: A Phase 2/3 Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P2/3 | N=7 | Terminated | Sponsor: Radius Pharmaceuticals, Inc. | N=220 ➔ 7 | Trial completion date: Aug 2024 ➔ Oct 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jul 2024 ➔ Oct 2022; Due to a change in corporate priorities, this study was voluntarily terminated by the Sponsor for reasons other than safety

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Prader–Willi syndrome

SCOUT-016: A Phase 3 Extension Study of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Radius Pharmaceuticals, Inc. | N=200 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Prader–Willi syndrome

SCOUT-015: A Phase 2/3 Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P2/3 | N=220 | Active, not recruiting | Sponsor: Radius Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Prader–Willi syndrome

A Phase 3 Extension Study of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Radius Pharmaceuticals, Inc.

New P3 trial • Prader–Willi syndrome

SCOUT-015: A Phase 2/3 Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P2/3 | N=220 | Recruiting | Sponsor: Radius Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Prader–Willi syndrome

Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers (clinicaltrials.gov) - P1/2; N=18; Completed; Sponsor: University of California, Los Angeles; Active, not recruiting ➔ Completed

Clinical • Trial completion • Pain

Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers (clinicaltrials.gov) - P1/2; N=18; Active, not recruiting; Sponsor: New York State Psychiatric Institute; Trial primary completion date: Dec 2017 ➔ Dec 2018

Trial primary completion date • Biosimilar • CNS Disorders • Pain

"#INSYS Therapeutics Initiates Ph3 Clinical Trial of #Cannabidiol (CBD) Oral Solution for Treatment of #InfantileSpasms — CheckOrphan https://t.co/WB2Ai1T8lm @RareDiseases @RareConnect @raredisorders" (@CheckOrphan)

Clinical • Biosimilar

Insys Therapeutics reports first quarter 2018 results (GlobeNewswire) - "Commenced enrollment in Phase 2 clinical trial of cannabidiol (CBD) oral solution as potential treatment for childhood absence epilepsy...Initiated Phase 3 clinical trial of CBD oral solution as potential treatment for infantile spasms."

Enrollment status • Trial initiation date • CNS Disorders • Epilepsy

Clinical data from long-term safety-study of company’s pharmaceutical CBD in refractory pediatric epilepsy to be presented at American Epilepsy Society Meeting (GlobeNewswire) - "Clinical data from a long-term safety study of pharmaceutical-grade cannabidiol (CBD) oral solution...for refractory pediatric epilepsy will be presented on Dec. 3 at the 2018 American Epilepsy Society (AES) annual meeting in New Orleans....Other clinical research on CBD from INSYS includes three ongoing company-sponsored trials: childhood absence epilepsy (Phase 2), infantile spasms (Phase 3)...Results from the Phase 2 trial in childhood absence epilepsy are expected soon, pending completion of enrollment. All three trials are actively enrolling patients."

Clinical data • Enrollment status • P2 data • CNS Disorders • Epilepsy

Cannabis oral solution now available for qualifying patients in Ireland (Health Europa) - "Tilray...announced its 10:10 THC/CBD medical cannabis oral solution has been approved for use under Ireland’s Medical Cannabis Access Program (MCAP)....The approved product is available in Ireland from United Drug Wholesale."

European regulatory • Launch Europe

A Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms (clinicaltrials.gov) - P3; N=190; Active, not recruiting; Sponsor: INSYS Therapeutics Inc; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers (clinicaltrials.gov) - P1/2; N=18; Active, not recruiting; Sponsor: New York State Psychiatric Institute; Trial completion date: Dec 2018 ➔ Dec 2021; Trial primary completion date: Dec 2018 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date